An Open-Label Study to Explore the Clinical Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant in HIV-HCV infected patients

Phase 1

• Conditions: Individuals with HIV-HCV co-infection and end-stage liver disease, with an indication for liver transplantation; MedDRA version: 17.0Level: HLTClassification code 10057212Term: Hepatitis viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001739-35-IT
• Lead Sponsor: niversità di Modena e ReggioEmilia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-08
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Males or females at least 18 years old at Screening. Subjects or their heterosexual partner(s) must either be of non-childbearing potential or they must use effective contraception from 2 weeks before the initiation of therapy until 6 months after the last dose of study medication.
2.HIV-HCV Co-infection documented with HIV-Ab and HCV RNA positivity
2.1Chronic HCV-infection, any genotypes, documented by at least one measurement of serum HCV RNA above the lower limit of quantification (LLoQ) measured during Screening
2.2 Chronic HIV infection undergoing antiretroviral therapy for at least 6 month with HIV Viral Load < 40 copies/ml
3. End stage Liver disease (ESLD) or HCC secondary to HCV meeting the MILAN criteria with a MELD between 15 and 35 and waiting list for OLT
4. Subjects must be naïve to treatment with NS5B polymerase inhibitors for chronic HCV infection.
5. A body mass index (BMI) of >=18 kg/m2.
6. Able to effectively communicate with the Investigator and other center personnel. Willing to give written informed consent and comply with the study restrictions and requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any transplant patient who has agreed to a liver transplant from a live donor.
2. Patients requiring planned induction therapy with biologics post-transplantation or with a post-transplantation immunosuppressive regimen not consistent with:
o Solumedrol/Prednisone
o Tacrolimus (maintaining a serum level of 5-12 ng/mL)
3. Chronic medical conditions, especially if treated with medications (such as hypertension), must be stable at the time of screening and first dose.
4. Clinically significant ECG findings at screening, screening QTc = 500 ms (cirrhotic), or a personal or family history of Torsades de pointes
5. History of major organ transplantation with an existing functional graft.
6. Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
7. Abnormal hematological and biochemical parameters, including:
a.neutrophil count <1000 cells/mm3
b. Hgb <8 g/dL without erythroid stimulating agents or blood transfusion
c. platelet count =10 000 cells/mm3
d. ALT or AST =10 times ULN
e. sodium <130 mmol/L
f. serum bilirubin > 30 mg/dL
g. serum albumin < 2.0 g/dL
h. INR >2
8. History of clinically significant drug allergy to nucleoside/nucleotide analogs.
9. Participation in any other clinical trial within 3 months prior to screening visit and during the study
10. History of having received any systemic antineoplastic or immunomodulatory treatment (including radiation) within 3 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study (excluding a local regional therapy such as TACE).
11. Treatment with TACE or RFA within 30 days prior to the first dose.
12. Pregnant/Breastfeeding women or males whose partners are currently pregnant.
13. Poor venous access making the patient unable to complete the required laboratory testing schedule.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified